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NCT02924766 · ClinicalTrials.gov registry record · Phase 1
A Safety and Pharmacokinetics Study of Niraparib Plus an Androgen Receptor-Targeted Therapy in Men With Metastatic Castration-Resistant Prostate Cancer (BEDIVERE)
A Phase 1 study of Prostatic Neoplasms, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 1
- Development phase
- 34
- Enrollment target
- 6
- Study locations
NCT02924766: Completed Phase 1 study of Prostatic Neoplasms, sponsored by Janssen Research & Development.
NCT02924766 is a Phase 1 study of Prostatic Neoplasms that has completed, run by Janssen Research & Development. The registered enrollment target is 34 participants, below the 514-participant average among 65 other Prostatic Neoplasms trials with a reported enrollment target (93% lower). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02924766, a Phase 1 study of Prostatic Neoplasms, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 34 participants
- Enrollment target
- 6
- Study locations
Study Summary
The purpose of this study is to assess the safety and pharmacokinetics of niraparib when administered in combination with an androgen receptor (AR)-targeted therapy (apalutamide or abiraterone acetate plus prednisone) in adult men with metastatic castration resistant prostate cancer (mCRPC) who may or may not have deoxyribonucleic acid (DNA)-repair anomalies.
Primary Outcome
RP2D will be defined as the highest dose of study drug at which less than 33 percent (%) of participants experience dose limiting toxicity (DLT).
Conditions Studied
Interventions
- DRUG Apalutamide
- DRUG Prednisone
- DRUG Abiraterone Acetate
- DRUG Niraparib
Study Locations (6)
California
- - West Hollywood
Kentucky
- - Louisville
Oregon
- - Portland
South Carolina
- - Myrtle Beach
British Columbia
- - Vancouver
Quebec
- - Montreal
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2016-10-03 |
| Est. Completion | 2019-07-19 |
| Phase | Phase 1 |
What the finished NCT02924766 record still lists
NCT02924766 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 514-participant average among 65 other Prostatic Neoplasms trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Prostatic Neoplasms appearing as the primary indexed condition, and to 4 interventions - of which Apalutamide is the first listed.
NCT02924766 lists 6 locations in 6 states (California, Kentucky, Oregon).
Frequently Asked Questions
What is clinical trial NCT02924766 about?
NCT02924766 is a clinical study titled "A Safety and Pharmacokinetics Study of Niraparib Plus an Androgen Receptor-Targeted Therapy in Men With Metastatic Castration-Resistant Prostate Cancer (BEDIVERE)". The purpose of this study is to assess the safety and pharmacokinetics of niraparib when administered in combination with an androgen receptor (AR)-targeted therapy (apalutamide or abiraterone acetate plus prednisone) in adult men with metastatic castration resistant prostate cancer (mCRPC) who may ...
What is the current status of trial NCT02924766?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 34 participants. The study started on 2016-10-03. Estimated completion is 2019-07-19.
What conditions does trial NCT02924766 study?
This clinical trial studies the following conditions: Prostatic Neoplasms.
What interventions are being tested in trial NCT02924766?
The interventions under investigation include: Apalutamide (DRUG), Prednisone (DRUG), Abiraterone Acetate (DRUG), Niraparib (DRUG).
Who is sponsoring clinical trial NCT02924766?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02924766 being conducted?
This trial has 6 study locations across California, Kentucky, Oregon, South Carolina, British Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02924766's enrollment target sits among peer trials
34 52nd of 65 higher than 14 of 65 other Prostatic Neoplasms trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostatic Neoplasms trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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